Device Recall EndoVive 3s Low Profile Balloon Kits

  • Model / Serial
    Part Number: M00548510 (XMD P/N 70-0050-216)  Lot Numbers: 928914
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution to MA only.
  • Product Description
    EndoVive 3s Low Profile Balloon Kits || Part Number: || M00548510 || (XMD P/N 70-0050-216) || The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Xeridiem Mediem Medical Devices Inc, 4700 S Overland Dr, Tucson AZ 85714-3430
  • Source
    USFDA

103 devices with a similar name

Learn more about the data here

  • Model / Serial
    Part Number: M00548280 (XMD P/N 70-0050-712)  Lot Number: 929604
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution to MA only.
  • Product Description
    EndoVive 3s Low Profile Balloon Kits || Part Number: || M00548280 || (XMD P/N 70-0050-712) || The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
  • Manufacturer
  • Model / Serial
    Part Number: M00548400 (XMD P/N 70-0050-714)  Lot Number: 928912
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution to MA only.
  • Product Description
    EndoVive 3s Low Profile Balloon Kits || Part Number: || M00548400 || (XMD P/N 70-0050-714) || The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
  • Manufacturer
  • Model / Serial
    Part Number: M00548560 (XMD P/N 70-0050-716)  Lot Number: 929626
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution to MA only.
  • Product Description
    EndoVive 3s Low Profile Balloon Kits || Part Number: || M00548560 || (XMD P/N 70-0050-716) || The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
  • Manufacturer
  • Model / Serial
    Part Number: M00548720 (XMD P/N 70-0050-718)  Lot Number: 928923 929713
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution to MA only.
  • Product Description
    EndoVive 3s Low Profile Balloon Kits || Part Number: || M00548720 || (XMD P/N 70-0050-718) || The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
  • Manufacturer
  • Model / Serial
    Part Number: M00548880 (XMD P/N 70-0050-720)  Lot Number: 930129
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution to MA only.
  • Product Description
    EndoVive 3s Low Profile Balloon Kits || Part Number: || M00548880 || (XMD P/N 70-0050-720) || The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
  • Manufacturer
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